Magellan Diagnostics is recalling several of its blood lead tests that may be producing inaccurate results, according to a notice from the Food and Drug Administration (FDA).
“The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals,” the notice says.
Lead exposure has been associated with health, learning and behavior problems, and no amount is considered safe.
The recall includes the LeadCare II lots 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M and 2107M as well as the LeadCare Plus and LeadCare Ultra lots 2011MU, 2104MU and 2108MU.
Clinicians and laboratories should re-evaluate patient results from these tests and use an alternative testing option to confirm suspect results, according to the FDA. Those may include inductively coupled mass spectrometry or graphite furnace atomic absorption spectrometry at a high complexity, Clinical Laboratory Improvement Amendments-certified reference laboratory.
Customers should stop using the recalled tests and complete the notification form in the recall letter they received, even if they no longer have tests remaining. They also should contact Magellan technical support at 800- 275-0102 to obtain a FedEx label to return remaining inventory.
Clinicians with questions can contact Magellan at the number above or LeadCareSupport@magellandx.com. They should report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Several of Magellan’s tests also were recalled in 2017. At that time, federal officials found multiple flaws in the company’s practices.